EN ISO/IEC 17043:2010

SLOVENSKI STANDARD
01-april-2010
Ugotavljanje skladnosti - Splošne zahteve za preskušanje strokovne
usposobljenosti (ISO/CASCO 17043:2010)
Conformity assessment - General requirements for proficiency testing (ISO/CASCO
17043:2010)
Konformitätsbewertung - Allgemeine Anforderungen an Eignungsprüfungen
(ISO/CASCO 17043:2010)
Évaluation de la conformité - Exigences générales concernant les essais d'aptitude
(ISO/CASCO 17043:2010)
Ta slovenski standard je istoveten z: EN ISO/IEC 17043:2010
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO/IEC 17043
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2010
ICS 03.120.20
English version
Conformity assessment - General requirements for proficiency
testing (ISO/CASCO 17043:2010)
Évaluation de la conformité - Exigences générales Konformitätsbewertung - Allgemeine Anforderungen an
concernant les essais d'aptitude (ISO/CASCO 17043:2010) Eignungsprüfungen (ISO/CASCO 17043:2010)
This European Standard was approved by CEN on 30 January 2010.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving
this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning
such national standards may be obtained on application to the CEN Management Centre or to any CEN and CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN Management Centre has the same
status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
CEN Management Centre: CENELEC Central Secretariat:
Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels
© 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEC 17043:2010 E
worldwide for CEN national Members and for CENELEC
Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO/IEC 17043:2010) has been prepared by Technical Committee ISO/CASCO
"Committee on conformity assessment" in collaboration with Technical Committee CEN/CLC/TC 1 "Criteria for
conformity assessment bodies", the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by August 2010, and conflicting national standards shall be withdrawn at
the latest by August 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO/CASCO 17043:2010 has been approved by CEN as a EN ISO/IEC 17043:2010 without any
modification.

INTERNATIONAL ISO/IEC
STANDARD 17043
First edition
2010-02-01
Conformity assessment — General
requirements for proficiency testing
Évaluation de la conformité — Exigences générales concernant les
essais d'aptitude
Reference number
ISO/IEC 17043:2010(E)
©
ISO 2010
ISO/IEC 17043:2010(E)
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ii © ISO 2010 — All rights reserved

ISO/IEC 17043:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Technical Requirements.4
4.1 General .4
4.2 Personnel .4
4.3 Equipment, accommodation and environment .5
4.4 Design of proficiency testing schemes.6
4.5 Choice of method or procedure.10
4.6 Operation of proficiency testing schemes.11
4.7 Data analysis and evaluation of proficiency testing scheme results .12
4.8 Reports .13
4.9 Communication with participants.14
4.10 Confidentiality.15
5 Management requirements.15
5.1 Organization.15
5.2 Management system .16
5.3 Document control.17
5.4 Review of requests, tenders and contracts.18
5.5 Subcontracting services.19
5.6 Purchasing services and supplies .19
5.7 Service to the customer.20
5.8 Complaints and appeals .20
5.9 Control of nonconforming work .20
5.10 Improvement .20
5.11 Corrective actions .21
5.12 Preventive actions.21
5.13 Control of records .22
5.14 Internal audits .22
5.15 Management reviews .23
Annex A (informative) Types of proficiency testing schemes .24
Annex B (informative) Statistical methods for proficiency testing.28
Annex C (informative) Selection and use of proficiency testing.35
Bibliography.39

ISO/IEC 17043:2010(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are members of
ISO or IEC participate in the development of International Standards through technical committees
established by the respective organization to deal with particular fields of technical activity. ISO and IEC
technical committees collaborate in fields of mutual interest. Other international organizations, governmental
and non-governmental, in liaison with ISO and IEC, also take part in the work. In the field of conformity
assessment, the ISO Committee on conformity assessment (CASCO) is responsible for the development of
International Standards and Guides.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
Draft International Standards are circulated to the national bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the national bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/IEC 17043 was prepared by the ISO Committee on conformity assessment (CASCO).
It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both
organizations.
This first edition of ISO/IEC 17043 cancels and replaces ISO/IEC Guide 43-1:1997 and
ISO/IEC Guide 43-2:1997, which have been technically revised.

iv © ISO 2010 — All rights reserved

ISO/IEC 17043:2010(E)
Introduction
Interlaboratory comparisons are widely used for a number of purposes and their use is increasing
internationally. Typical purposes for interlaboratory comparisons include:
a) evaluation of the performance of laboratories for specific tests or measurements and monitoring
laboratories' continuing performance;
b) identification of problems in laboratories and initiation of actions for improvement which, for example, may
be related to inadequate test or measurement procedures, effectiveness of staff training and supervision,
or calibration of equipment;
c) establishment of the effectiveness and comparability of test or measurement methods;
d) provision of additional confidence to laboratory customers;
e) identification of interlaboratory differences;
f) education of participating laboratories based on the outcomes of such comparisons;
...